Systems and methods for prostate treatment

ABSTRACT

A vapor delivery needle is provided that may include any of a number of features. One feature of the energy delivery probe is that it can apply condensable vapor energy to tissue, such as a prostrate, to shrink, damage, denaturate the prostate. In some embodiments, the needle can ablate a continuous lobe region in the prostate parallel to the urethral wall. Another feature of the vapor delivery needle is that it can introduce a cooling fluid into the urethra during treatment. Methods associated with use of the energy delivery probe are also covered.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/072,573, filed Mar. 25, 2011, which application claims the benefitunder 35 U.S.C. 119 of U.S. Provisional Patent Application No.61/317,358, filed Mar. 25, 2010, titled “Systems and Methods forProstate Treatment”, both of which are incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications, including patents and patent applications, mentionedin this specification are herein incorporated by reference in theirentirety to the same extent as if each individual publication wasspecifically and individually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to devices and related methods fortreatment of benign prostatic hyperplasia using a minimally invasiveapproach.

BACKGROUND OF THE INVENTION

Benign prostatic hyperplasia (BPH) is a common disorder in middle-agedand older men, with prevalence increasing with age. At age 70, more thanone-half of men have symptomatic BPH, and nearly 90% of men havemicroscopic evidence of an enlarged prostate. The severity of symptomsalso increase with age with 27% of patients in the 60-70 age brackethaving moderate-to-severe symptoms, and 37% of patients in their 70' ssuffering from moderate-to-severe symptoms.

The prostate early in life is the size and shape of a walnut and weighsabout 20 grams. Prostate enlargement appears to be a normal process.With age, the prostate gradually increases in size to twice or more itsnormal size. The fibromuscular tissue of the outer prostatic capsulerestricts expansion after the gland reaches a certain size. Because ofsuch restriction on expansion, the intracapsular tissue will compressagainst and constrict the prostatic urethra thus causing resistance tourine flow.

FIG. 1 is a sectional schematic view the male urogenital anatomy, withthe walnut-sized prostate gland 100 located below the bladder 105 andbladder neck indicated at 106. The walls 108 of bladder 105 can expandand contract to cause urine flow through the urethra 110, which extendsfrom the bladder 105, through the prostate 100 and penis 112. Theportion of urethra 110 that is surrounded by the prostate gland 100 isreferred to as the prostatic urethra 120. The prostate 100 alsosurrounds the ejaculatory ducts 122 which have an open termination inthe prostatic urethra 120. During sexual arousal, sperm is transportedfrom the testes 124 by the ductus deferens 126 to the prostate 100 whichprovides fluids that combine with sperm to form semen duringejaculation. On each side of the prostate, the ductus deferens 126 andseminal vesicles 128 join to form a single tube called an ejaculatoryduct 122. Thus, each ejaculatory duct 122 carries the seminal vesiclesecretions and sperm into the prostatic urethra 120.

Referring to FIGS. 2A-2C, the prostate glandular structure can beclassified into three zones: the peripheral zone, transition zone, andcentral zone. The peripheral zone PZ, which is the region forming thepostero-inferior aspect of the gland, contains 70% of the prostateglandular elements in a normal prostate (FIGS. 2A-2C). A majority ofprostate cancers (up to 80%) arise in the peripheral zone PZ. Thecentral zone CZ surrounds the ejaculatory ducts 122 and contains about20-25% of the prostate volume. The central zone is often the site ofinflammatory processes. The transition zone TZ is the site in whichbenign prostatic hyperplasia develops, and contains about 5-10% of thevolume of glandular elements in a normal prostate (FIG. 2C), but canconstitute up to 80% of such volume in cases of BPH. The transition zoneTZ consists of two lateral prostate lobes and the periurethral glandregion indicated at 130. As can be understood from FIGS. 2A-2C, thereare natural barriers around the transition zone TZ, i.e., the prostaticurethra 120, the anterior fibromuscular stroma FS, and a fibrous planeFP between the transition zone TZ and peripheral zone PZ. In FIGS.2A-2C, the anterior fibromuscular stroma FS or fibromuscular zone can beseen and is predominantly fibromuscular tissue.

BPH is typically diagnosed when the patient seeks medical treatmentcomplaining of bothersome urinary difficulties. The predominant symptomsof BPH are an increase in frequency and urgency of urination. BPH canalso cause urinary retention in the bladder which in turn can lead tolower urinary tract infection (LUTI). In many cases, the LUTI then canascend into the kidneys and cause chronic pyelonephritis, and caneventually lead to renal insufficiency. BPH also may lead to sexualdysfunction related to sleep disturbance or psychological anxiety causedby severe urinary difficulties. Thus, BPH can significantly alter thequality of life with aging of the male population.

BPH is the result of an imbalance between the continuous production andnatural death (apoptosis) of the glandular cells of the prostate. Theoverproduction of such cells leads to increased prostate size, mostsignificantly in the transitional zone which traverses the prostaticurethra.

In early stage cases of BPH, treatments can alleviate the symptoms. Forexample, alpha-blockers treat BPI-I by relaxing smooth muscle tissuefound in the prostate and the bladder neck, which may allow urine toflow out of the bladder more easily. Such drugs can prove effectiveuntil the glandular elements cause overwhelming cell growth in theprostate.

More advanced stages of BPH, however, can only be treated by surgicalinterventions. A number of methods have been developed usingelectrosurgical or mechanical extraction of tissue, and thermal ablationor cryoablation of intracapsular prostatic tissue. In many cases, suchinterventions provide only transient relief, and there often issignificant peri-operative discomfort and morbidity.

In a prior art thermal ablation method, RF energy is delivered toprostate tissue as schematically depicted in FIGS. 3A-3B. FIG. 3Adepicts the elongated prior art RF needle being penetrated into aplurality of locations in a prostate lobe. In a first aspect of theprior art method, the elongated RF needle typically is about 20 mm inlength, together with an insulator that penetrates into the lobe. Theresulting RF treatment thus ablates tissue away from the prostaticurethra 120 and does not target tissue close to, and parallel to, theprostatic urethra 120. In another aspect of the prior art RF method, theapplication of RF energy typically extends for 1 to 3 minutes or longerwhich allows thermal diffusion of the ablation to reach the capsuleperiphery. Such prior art RF energy delivery methods may not create adurable effect, since smooth muscle tissue and alpha adrenergicreceptors are not uniformly ablated around the prostatic urethra. As aresult, tissue in the lobes can continue to grow and impinge on theurethra thus limiting long term effectiveness of the treatment.

SUMMARY OF THE INVENTION

In some embodiments, a method for treating benign prostatic hyperplasiaof a prostate of a patient is provided, comprising inserting a vapordelivery needle through a urethral wall of the patient in a plurality oflocations into a prostate lobe, delivering condensable water vaporthrough the needle into the prostate at each location, and ablating acontinuous lobe region parallel to the urethral wall.

In some embodiments, the continuous lobe region is between a bladderneck and a verumontanum of the patient.

In some embodiments, the inserting step comprises inserting a tip of thevapor delivery needle 15 mm or less through the urethral wall into theprostate lobe.

In other embodiments, the ablating step comprises ablating thecontinuous lobe region extending less than 2 cm away from the urethralwall.

In some embodiments, the delivering step comprises delivering thecondensable water vapor for less than 30 seconds.

In one embodiment, the method can further comprise introducing a coolingfluid into the urethra during the delivering step. Some embodimentsfurther comprise inserting a vapor delivery tool shaft into the urethra,the vapor delivery needle being at least partially disposed within theshaft, the cooling fluid being introduced into the urethra through theshaft. Another embodiment is provided, further comprising introducingthe cooling fluid into the urethra during the entire time condensablewater vapor is delivered into the prostate.

Some embodiments can further comprise sensing a temperature within theurethra and controlling delivery of the condensable vapor based on thesensed temperature. In one embodiment, the sensing a temperature stepcomprises sensing a temperature of the vapor delivery needle.

In some embodiments, the method further comprises viewing the insertingstep through an endoscope. In other embodiments, the method furthercomprises inserting a vapor delivery tool shaft into the urethra, thevapor delivery needle and the endoscope being at least partiallydisposed within the shaft. The method can further comprise introducing acooling fluid into the urethra during the delivering step, the coolingfluid being introduced into the urethra through the shaft around theendoscope. In some embodiments, the method further comprises viewingwith the endoscope a mark on the vapor delivery needle that is visibleonly when the needle is in one of a retracted position or a deployedposition.

In some embodiments, the plurality of locations in the prostate lobecomprise a first plurality of locations longitudinally spaced along theurethra, the method further comprising inserting the vapor deliveryneedle through the urethral wall in a second plurality of locations inthe prostate, the second plurality of locations being radially displacedfrom the first plurality of locations.

Another method for treating benign prostatic hyperplasia of a prostateof a patient is provided, comprising ablating a region of the prostateless than 2 cm away from urethra without ablating a peripheral lobeportion of the prostate.

In some embodiments, the method further comprises inserting anenergy-emitting section of a needle into the prostate, wherein theablating step comprises delivering energy to the prostate via theneedle.

In some embodiments, the inserting step comprises inserting the needletransurethrally.

In other embodiments, the inserting step comprises inserting the needletransurethrally into the prostate in a plurality of locations, theregion of the prostate comprising a continuous lobe region parallel tothe urethral wall.

In an additional embodiment, the inserting step comprises inserting theneedle transrectally.

A method for treating benign prostatic hyperplasia (BPH) is providedcomprising positioning an energy-emitting section of needle in aplurality of locations in a prostate lobe adjacent the prostaticurethra, and delivering energy at each location for less than 30 secondsto thereby confine thermal ablation to lobe tissue adjacent theprostatic urethra and preventing thermal diffusion to peripheral lobetissue.

In some embodiments, energy is delivered from a condensable vapor media.

In other embodiments, energy is delivered from a needle memberintroduced through a transurethral access path.

In some embodiments, the method further comprises introducing a coolingfluid into the urethra during the application of energy.

A method for treating benign prostatic hyperplasia of a prostate of apatient is provided, comprising inserting a vapor delivery needlethrough a urethral wall of the patient into the prostate, viewing theinserting step via an endoscope disposed in the urethra, deliveringcondensable water vapor through the needle into the prostate, andablating prostate tissue within the prostate.

In some embodiments, the method further comprises inserting a vapordelivery tool shaft into the urethra, the needle and the endoscope bothbeing at least partially disposed within the shaft.

Additionally, the method can further comprise, after the ablating step,retracting the needle, rotating the shaft and the needle within theurethra, inserting the vapor delivery needle through the urethral wallinto a different location in the prostate, delivering condensable watervapor through the needle into the prostate, and ablating prostate tissuewithin the prostate.

In some embodiments, the method comprises supporting the shaft with ahandle, the rotating step comprising rotating the handle with the shaft.In other embodiments, the method comprises supporting the shaft with ahandle, the rotating step comprising rotating the shaft without rotatingthe handle. In some embodiments, the rotating step further comprisesrotating the shaft and the needle without rotating the endoscope.

In one embodiment, the viewing step further comprises viewing a mark onthe needle that is visible only when the needle is in one of a retractedposition or a deployed position.

A vapor therapy system is provided, comprising a shaft adapted to beinserted into a male urethra, a vapor delivery needle in the shaft, theneedle comprising a vapor exit port, a scope bore in the shaft sized toaccommodate an endoscope, the bore having an opening oriented to permita user to view a distal end of the vapor delivery needle through theendoscope, a water vapor source, and a vapor delivery actuator adaptedto deliver water vapor from the water vapor source into the vapordelivery needle and out of the vapor exit port.

In some embodiments, the needle is movable between a retracted positionin which a distal needle tip is within the shaft and a deployed positionin which the distal needle tip extends from the shaft.

One embodiment of the system further comprises a vapor needle deploymentmechanism adapted to move a tip of the needle transverse to the shaft.In some embodiments, the deployment mechanism is adapted to move theneedle tip no more than 15 mm from the shaft.

In some embodiments, the system further comprises a marking on a distaltip portion of the vapor delivery needle. In one embodiment, the markingis visible through the bore when the needle is in the deployed positionbut not visible through bore opening when needle is in the retractedposition.

Some embodiments of the system further comprise a needle-retractionactuator adapted to retract the needle into the shaft.

In some embodiments, the needle is configured to deliver water vaporover a predetermined length less that 15 mm from shaft. In otherembodiments, the needle comprises a non-energy applicator portion thatdoes not include a vapor exit port. In some embodiments, the non-energyapplicator portion is approximately the thickness of the male urethra.

In some embodiments, the needle is a flexible polymer tube with sharptip.

In other embodiments, the needle is insulated. In one embodiment, theinsulated needle comprises a central bore surrounded by insulative airgap and an outer sleeve.

In some embodiments, the system further comprises an irrigation liquidsource and an irrigation passage in the shaft extending from theirrigation liquid source to an irrigation liquid outlet. In oneembodiment, the irrigation passage is within the bore. In anotherembodiment, the system comprises an irrigation actuator configured toirrigate a cooling fluid from the irrigation liquid source through theirrigation liquid outlet. In one embodiment, the irrigation liquidsource is connected to the irrigation passage. In another embodiment,the irrigation actuator is configured to irrigate the cooling fluid whenthe vapor delivery actuator delivers water vapor.

In some embodiments, the system further comprises an interlock toprevent water vapor delivery without irrigation of the cooling fluid.

In some embodiments, the system further comprises a bridge element inthe opening of the bore configured to prevent tissue from falling intothe opening of the bore.

In some embodiments, the shaft has blunt distal tip and the opening ofthe bore is proximal to a distal end of the shaft.

In some embodiments, the system further comprises a handle connected tothe shaft through an adjustably rotatable connector such that shaft canbe rotated with respect to the handle. In some embodiments, therotatable connector comprises rotational stops at preset angles.

In some embodiments, the system further comprises a temperature sensoroperably connected to a controller to control vapor delivery based on asensed temperature. In one embodiment, the temperature sensor isconfigured to sense needle temperature. In another embodiment, thetemperature sensor is configured to sense shaft temperature.

A vapor therapy system is provided, comprising a shaft adapted to beinserted into a male urethra, a vapor delivery needle in the shaft, theneedle comprising a vapor exit port, a vapor needle deployment mechanismadapted to move a tip of the needle transverse to the shaft no more than15 mm from the shaft, a water vapor source; and a vapor deliveryactuator adapted to deliver water vapor from the water vapor source intothe vapor delivery needle and out of the vapor exit port.

In some embodiments, the vapor needle deployment mechanism comprises anactuator adapted to deploy an actuation force on the needle to deploythe needle.

In other embodiments, the vapor needle deployment mechanism furthercomprises a needle deployment spring.

In some embodiments, the system further comprises a vapor deliveryinterlock adapted to prevent delivery of water vapor from the vapordelivery needle unless the needle is deployed.

In some embodiments, the needle deployment mechanism further comprises alimit stop adapted to limit a deployment distance of the needle.

In some embodiments, the system further comprises a needle-retractionactuator adapted to retract the needle into the shaft.

In some embodiments, the system further comprises a scope bore in theshaft sized to accommodate an endoscope, the bore having an openingoriented to permit a user to view a distal end of the vapor deliveryneedle through the endoscope.

In other embodiments, the system further comprises a marking on a distaltip portion of the vapor delivery needle. In one embodiment, the markingis visible through the bore opening when the needle is in a deploymentposition but the marking is not visible through the bore opening whenthe needle is in a retracted position.

In some embodiments, the needle is a flexible polymer tube with a sharptip.

In other embodiments, the needle is insulated. In some embodiments, theinsulated needle comprises a central bore surrounded by an insulativeair gap and an outer sleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better understand the invention and to see how it may becarried out in practice, some preferred embodiments are next described,by way of non-limiting examples only, with reference to the accompanyingdrawings, in which like reference characters denote correspondingfeatures consistently throughout similar embodiments in the attacheddrawings.

FIG. 1 is a sectional schematic view the male urogenital anatomy.

FIG. 2A-2C are views of a patient's prostate showing zones of prostatetissue.

FIG. 3A is a sectional view of a normal prostate gland.

FIG. 3B is a sectional view of a prostate gland with BPH.

FIG. 4 is a perspective view of a probe corresponding to the invention.

FIG. 5 is a view of components within a handle portion of the probe ofFIG. 4.

FIG. 6 is another view of components within a handle portion of theprobe of FIG. 4.

FIG. 7 is a cross sectional view of a probe.

FIG. 8 is a side view of a microcatheter or needle of a probe.

FIG. 9 is a side elevation view of the microcatheter or needle of theprobe of FIG. 4 showing its dimensions and vapor outlets.

FIG. 10 is another view of the microcatheter of FIG. 9.

FIG. 11 is another view of a distal portion of the microcatheter of FIG.10.

FIG. 12 is a sectional view of the microcatheter of FIG. 10 taken alongline 11-11 of FIG. 10.

FIGS. 13A-13B are schematic views of the probe of FIG. 4 in a head-onview in a prostate indicating the radial angle of the probe as it isrotated in situ to treat lateral prostate lobes.

FIGS. 14A-14B are schematic views similar to that of FIGS. 13A-13Bshowing a method of rotating certain components of the probe againindicating the radial angles of the penetrating microcatheter of theprobe of FIG. 4, while leaving the probe handle in a non-rotatedposition.

FIGS. 15A-15B are schematic views similar to that of FIGS. 13A-13Bshowing a method of rotating other components of the probe, againindicating the radial angles of the penetrating microcatheter in thelateral lobes of the prostate while leaving the probe handle in anon-rotated position.

FIG. 16A is a longitudinal sectional schematic view showing a method ofthe invention in treating a prostate for BPH.

FIG. 16B is a transverse sectional view of the prostate of FIG. 16A.

FIG. 17 is another longitudinal sectional view showing ablation zones inthe method of treating a prostate for BPH.

FIG. 18 is an MRI from a patient 1 week after a treatment as indicatedschematically in FIGS. 16A-17.

FIG. 19 is a block diagram of a method corresponding to the invention.

FIG. 20 is a block diagram of another method corresponding to theinvention.

FIG. 21 is a block diagram of another method corresponding to theinvention.

DETAILED DESCRIPTION OF THE INVENTION

In general, one method of the invention for treating BPH comprisesintroducing a heated vapor interstitially into the interior of aprostate, wherein the vapor controllably ablates prostate tissue. Thismethod can utilize vapor for applied energy of between 50 calories and200 calories per lobe in an office-based procedure. The method can causelocalized ablation of prostate tissue, and more particularly the appliedenergy from vapor can be localized to ablate tissue adjacent the urethrawithout damaging prostate tissue that is not adjacent the urethra.

The present invention is directed to the treatment of BPH, and moreparticularly for ablating transitional zone prostate tissue withoutablating peripheral zone prostate tissue.

In one embodiment, the present invention is directed to treating aprostate using convective heating in a region adjacent the prostaticurethra.

In one embodiment, the method of ablative treatment is configured totarget smooth muscle tissue, alpha adrenergic receptors, and sympatheticnerve structures parallel to the prostatic urethra between the bladderneck region and the verumontanum region to a depth of less than 2 cm.

In one embodiment, the system includes a vapor delivery mechanism thatdelivers water vapor. The system can utilize a vapor source configuredto provide vapor having a temperature of at least 60° C., 80° C., 100°C., 120° C., or 140° C.

In another embodiment, the system further comprises a computercontroller configured to deliver vapor for an interval ranging from 1second to 30 seconds.

In another embodiment, the system further comprises a source of apharmacologic agent or other chemical agent or compound for deliverywith the vapor. The agent can be an anesthetic, and antibiotic or atoxin such as Botox®. The agent can also be a sealant, an adhesive, aglue, a superglue or the like.

Another method of the invention provides a treatment for BPH that canuse transrectal approach using a TRUS (ultrasound system as an imagingmeans to image the prostate, and navigate a vapor delivery tool to thetreatment sites.

In another method of the invention, the tool or needle working end canbe advanced manually or at least in part by a spring mechanism.

In another aspect of the invention, the system may contemporaneouslydeliver cooling fluids to the urethra during an ablation treatment toprotect the interior lining of the urethra.

FIGS. 4, 5 and 6 depict one embodiment of probe 100 of the system of theinvention that is adapted for trans-urethral access to the prostrate andwhich provides viewing means to view the urethra as the probe innavigated to a site in the interior of the patient's prostate. The probe100 further carries an extendable and retractable microcatheter member105 (FIGS. 5-6) having a distal tip portion 108 (FIG. 4) that can bepenetrated into precise targeted locations in prostate lobes to ablatetargeted tissue volumes.

Handle and Introducer Portion

In FIG. 4, it can be seen that probe 100 has an elongate introducerportion 110 for insertion into the urethra and a handle portion 111 forgripping with a human hand. The key structural component of introducerportion 110 comprises a rigid introducer sleeve or extension sleeve 112extending along longitudinal axis 113 with proximal end 114 a and distalend 114 b. The bore 115 in the rigid extension sleeve extends alonglongitudinal axis 116. In one embodiment, referring to FIGS. 4 and 5,the extension sleeve 112 comprises a thin-wall stainless steel tube withbore 115 dimensioned to receive a commercially available viewing scopeor endoscope 118. The schematic cut-away view of FIG. 5 shows structuralbulkhead 120 coupled to a medial portion 122 of extension sleeve 112.The structure or bulkhead 120 comprises the structural member to whichthe molded handle having pistol grip 124, and more particularly theright- and left-side mating handle parts, 125 a and 125 b, are coupled(FIG. 4). The bulkhead can be a plastic molded part that can be fixed tosleeve 112 or rotationally coupled to sleeve 112.

Referring to FIGS. 5-6, in which the molded handle left and right sidesare not shown, it can be seen that bore 115 in sleeve 112 has a proximalopen end 130 into which the endoscope 118 can be inserted. The proximalend portion 114 a of extension sleeve 112 is coupled to an adaptermechanism 132 that releasably engages the endoscope 118 and rotationallyaligns the scope 118 with the introducer portion 110. The endoscope 118has a proximal viewing end 135 and light connector 136 extending outwardfrom the viewing end 136 for coupling a light source 140 to theendoscope. FIG. 7 illustrates that bore 115 in sleeve 112 has a diameterranging from about 2 to 5 mm for accommodating various endoscopes 118,while at the same time providing an annular space 138 for allowing anirrigation fluid to flow through bore 115 and outwardly from theintroducer portion.

In one embodiment of system 100, referring to FIGS. 5-8, theextendable-retractable microcatheter 105 comprises a thin-wall flexiblepolymer tube with a sharp tip that is axially slidable in a passageway148 in the introducer portion 110. FIGS. 4, 7 and 9 show that theintroducer portion 110 comprises an elongate introducer body 144 ofplastic or another suitable material that surrounds extension sleeve112. The introducer body 144 extends to a distal working end portion 145having a blunt nose or tip 146 for advancing through the urethra. Theelongate introducer body 144 is further configured with passageway 148that accommodates the microcatheter member 105 as will be describedbelow. Referring to FIGS. 8-9, the distal end portion 145 of theintroducer body 144 is configured with openings 160 that open to centralopen region 162 that is distal to the distal lens 164 of endoscope 118that allows for viewing of the urethra through the lens 164 of theendoscope during navigation. The endoscope 118 can have a lens with a30°, 12.5° or other angle for viewing through openings 160. As can beseen in FIGS. 8-9, the openings 160 have bridge elements 165therebetween that function to prevent tissue from falling into centralopen region 162 of the introducer body 144. In FIG. 8, it can be seenthat the working end portion 105 of the flexible microcatheter shaft 105is disposed adjacent to open region 162 and thus can be viewed throughthe endoscope lens 164.

Microcatheter and Spring-actuator

FIGS. 10-11 show the flexible microcatheter member or needle 105de-mated from the probe 100 to indicate its repose shape. In oneembodiment, the microcatheter 105 has a first (proximal) largercross-section portion 170 that necks down to second (distal)cross-section portion 175 wherein the smaller cross-section portion 175has a curved repose shape with the curve configured to conform withoutsignificant resistance to the contour of the curved axis 177 of the pathfollowed by the working end 108 of the microcatheter 105 as it is movedfrom its non-extended position to its extended position as shown inFIGS. 1, 8 and 9. In one embodiment, referring to FIGS. 10-12, themicrocatheter's first cross section portion 170 comprises a thin wallouter sleeve 180 that is concentrically outward from inner microcathetertube 185 that extends the length of the microcatheter member 105. As canbe seen in FIG. 12, the outer sleeve 180 provides a thermally insulativeair gap 188 around inner tubular member 185. In one embodiment showndepicted in FIG. 12, the outer sleeve 180 is configured withintermittent protrusions 190 that maintain the air gap 188 between theinner surface 192 of outer sleeve 180 and outer surface 193 of innermicrocatheter tube. FIG. 9 shows that the outer sleeve 180 has neckeddown portion 194 that is bonded to inner microcatheter tube 185 by anysuitable means such as ultrasonic bonding, adhesives or the like.Referring back to FIG. 10, both the outer sleeve 180 and inner tubularmember can comprise a high-temperature resistant polymer such as Ultem®that is suited for delivering a high temperature vapor as will bedescribed below. In one embodiment, the microcatheter tube 185 has anoutside diameter of 0.050″ with an interior lumen 195 of approximately0.030″. Referring to FIGS. 8-9, one embodiment of working end portion108 for delivering vapor media to tissue has a thin wall 198 with aplurality of outlet ports 200 therein that are configured for emitting avapor media into tissue as will be described below. The outlet ports canrange in number from about 2 to 100, and in one embodiment consist of 12outlets each having a diameter of 0.008″ in six rows of two outlets withthe rows staggered around the working end 108 as shown in FIG. 10. Inone embodiment shown in FIGS. 10-11, the distalmost tip 202 of themicrocatheter tube 185 has a sharpened conical configuration that can beformed of the plastic material of tube 185. As will be described below,it has been found that a polymeric needle and needle tip 202 is usefulfor its thermal characteristics in that its heat capacity will notimpinge on vapor quality during vapor delivery.

FIGS. 10-11 further illustrate that the distal tip portion 108 ofmicrocatheter tube 185 has at least one marking 204 that contrasts withthe color of the microcatheter tube 185 that is adapted for viewingthrough lens 164 of the endoscope 118. In one embodiment, the distal tipportion has a series of annular marks 204 of a first color thatcontrasts with second color of tube 185, wherein the marks are notvisible through the endoscope lens 164 when the microcatheter tube 185is in the non-extended position. After the microcatheter tube 185 isextended into tissue, the marks are visible through the lens 164 whichindicates the tube 185 has been extended into tissue.

Returning now to FIGS. 5 and 6, the cut-away view of the handle portion111 shows the microcatheter member 105 and associated assemblies in thenon-extended position. FIG. 5 shows flanges 208 a and 208 b of cockingactuator 210 are disposed on either side of actuator collar 212 that iscoupled to proximal end 214 of the slidable microcatheter member 105. Ascan be understood from FIG. 5, the downward-extending cocking actuator210 is adapted to cock the flanges 208 a, 208 b and microcatheter 105 toa cocked position which corresponds to the non-extended position of themicrocatheter 105. In FIG. 5, the actuator 210 is shown in a firstposition B (phantom view) and second positions B′ following actuationwith an index finger to thus cock the microcatheter member 105 to thesecond releasable non-extended position (or cocked position) B′ from itsextended position B. The flange 208 a and actuator 210 is further shownin phantom view in the released position indicated at 208 a′. In FIG. 5,the flanges 208 a, 208 b and associated assemblies are configured for anaxial travel range indicated at A that can range from about 8 mm to 15mm which corresponds to the travel of the microcatheter 105 andgenerally to the tissue-penetration depth. In the embodiment of FIG. 5,the flanges 208 a, 208 b and microcatheter member 105 arespring-actuatable to move from the non-extended position to the extendedposition by means of helical spring 215 disposed around sleeve 112. Ascan be seen in FIG. 5, the spring 215 is disposed between the slidableflange 208 b and trigger block 218 that comprises a superior portion ofthe release trigger 220 which is adapted to release the microcatheter105 from its cocked position.

FIG. 5 further illustrates the release trigger 220 releasablymaintaining the flange 205 a and microcatheter 105 in its cockedposition wherein tooth portion 222 of the trigger 220 engages the loweredge of flange 205 a. It can be understood from FIG. 5 that the releasetrigger 220 is configured to flex or pivot around living hinge portion224 when trigger 220 is depressed in the proximal direction by thephysician's finger actuation. After actuation of trigger 220 and releaseof the microcatheter 105 to move distally, the axial travel of theassembly is configured to terminate softly rather than abruptly asflange 208 a contacts at least one bumper element 230 as depicted inFIG. 6. The bumper elements 230 can comprise any spring or elastomericelement, and in FIG. 6 are shown as an elastomer element housed in ahelical spring, which serve to cushion and dampen the end of the travelof the spring-driven microcatheter assembly. The bumper elements 230 arecoupled to flange 235 which in turn is configured to be fixed betweenright- and left-side handle parts 125 a and 125 b (FIG. 4).

Now turning to the energy-delivery aspect of the system, a vapor source250 is provided for delivering a vapor media through the microcathetermember 105 to ablate tissue. The vapor source can be a vapor generatorthat can deliver a vapor media, such as water vapor, that has aprecisely controlled quality to provide a precise amount of thermalenergy delivery, for example measured in calories per second.Descriptions of suitable vapor generators can be found in the followingU.S. patent applications: application. Ser. Nos. 11/329,381; 60/929,632;61/066,396; 61/068,049; 61/068,130; 61/123,384; 61/123,412; 61/126,651;61/126,612; 61/126,636; 61/126,620 all of which are incorporated hereinby reference in their entirely. The vapor generation system also cancomprise an inductive heating system similar to that described inApplication Nos. 61/123,416, 61/123,417, 61/126,647. The system furtherincludes a controller 255 that can be set to control the variousparameters of vapor delivery, for example, the controller can be set todelivery vapor media for a selected treatment interval, a selectedpressure, or selected vapor quality.

Referring to FIG. 5, in one embodiment, the vapor source 250 is remotefrom the handle 124 and vapor media is carried to the handle by aflexible conduit 262 that couples handle and check valve 264 therein. Inone embodiment, vapor can be re-circulating in conduit 262 until asolenoid in the vapor source is actuated to cause the vapor flow to thusprovide an increased fluid pressure which opens the check valve 265 andallows the vapor media to flow through flexible tube 268 to valve 270that can be finger-actuated by trigger 275. In one embodiment depictedin FIG. 5, the trigger 275 is urged toward a non-depressed position byspring 277 which corresponds to a closed position of valve 270. Thetrigger 275 also can be coupled by an electrical lead (not shown) tocontroller 255. Thus, actuating the trigger 275 can cause the controllerto actuate a solenoid valve in the vapor generator to cause vapor flowthrough the relief valve. As a safety mechanism, the valve 270 in thehandle is opened only by its actuation to thus permit the flow of vapormedia through flexible tube 278 which communicates with inflow portportion 280 of collar 212 which in turn communicates with the lumen 195in the microcatheter 105. Thus, FIG. 5 illustrates the flow path andactuation mechanisms that provide vapor flow on demand from the vaporsource 250 to the vapor outlets 200 in working end 108 of themicrocatheter 105.

As can be seen in FIG. 5, the handle can also provide an interlockmechanism that prevents the actuation of vapor flow if the microcatheterrelease trigger is in the cocked position, wherein edge portion 292coupled to release trigger 220 can engage notch 294 in trigger 275 toprevent depression of said trigger 275.

Still referring to FIG. 5, one embodiment of the system includes a fluidirrigation source 300 that is operatively couple to the bore 115 inextension member 112 to deliver a fluid outward from the bore 115 to theopen region 162 of the probe working end 145 (see FIG. 8). As can beseen in FIG. 7, the bore 115 is dimensioned to provide a space 138 forfluid irrigation flow around the endoscope 118. In FIG. 5, it can beseen that fluid source 300, which can be a drip bag or controlledpressure source of saline or another fluid, is detachably coupled totubing 302 in the handle which extends to a valve 305 that can bethumb-operated from actuators 308 on either side of the handle. Thethumb actuator 308 can also control the rate of flow of the irrigationfluid by moving the actuator 308 progressively forward, for example, toopen the valve more widely open. The fluid flows from valve 305 throughtube 312 to a port or opening 315 in the extension sleeve 112 to thusenter the bore 115 of the sleeve.

FIG. 5 further depicts an aspiration source 320 operatively coupled totubing 322 in the handle 124 which also can be actuated by valve 305wherein the thumb actuator 308 can be rocked backwardly to allow suctionforces to be applied through the valve 305 to tubing 312 that extends toport 315 in the extension member—which is the same pathway of irrigationflows. Thus, suction or aspiration forces can withdraw fluid from theworking end of the device during a treatment.

Another aspect of one embodiment of probe 100 corresponding to theinvention, referring to FIGS. 4, 5, 6 and 8, is the orientation of themicrocatheter or needle 105 as it exits the working end 145 relative tothe orientation of the pistol grip 124 of the handle portion 111. In amethod use further described below, the introducer will typically beintroduced through the urethra with the pistol grip in a “grip-downward”orientation GD (FIG. 13A) with the pistol grip 126 oriented downwardlywhich comfortable for the physician. The treatment will typicallyinclude rotationally re-orienting the probe as indicated in FIG. 13A sothat the microcatheter or needle 105 can be penetrated into prostatelobes at 90° to about 135° relative to a grip-downward position. FIGS.13A and 13B are schematic head-on views of the probe 100 in a prostatewith the microcatheter 105 deployed showing the orientation of thehandle pistol grip 124, the deployed microcatheter 105 and the connectorendoscope 136 which indicate the rotational orientation of the endoscope118 and thus the orientation of the camera image on the monitor. As canbe seen in FIGS. 4-6, the assembly of the introducer 110, microcatheter105 and endoscope 118 is rotatable within the handle within flanges 235Aand 235B. In one embodiment, the system has click-stops at variousangles, such as every 15° between 75° and 135° relative to thegrip-downward orientation GD of FIG. 13A. Thus FIGS. 13A-13A and 14A-14Bdepict optional methods that the surgeon may use.

FIGS. 13A and 13B depict the physician locking all components of theprobe 100 in a single rotational orientation, and simply using hisrotating his hand and pistol grip 124 to a selected orientation ofgreater that 90° from the grip-down position GD, then releasing themicrocatheter 105 to penetrate into the prostate lobe. After actuatingthe vapor delivery trigger, the vapor ablates are region indicted at400. It can be appreciated that the endoscope 118 is rotated so that theimage on the monitor is also rotated. Thereafter, the physician rotatesthe probe as depicted in FIG. 13B to treat the other prostate lobe. Thismethod may be preferred by physicians that are familiar with anatomicallandmarks, opt for simplicity and are accustomed to viewing an image onthe monitor which is rotated relative a true vertical axis of thepatient anatomy.

FIGS. 14A and 14B depict the physician utilizing the rotational featureof the probe and maintaining the handle pistol grip 124 in the grip-downorientation GD and rotating the introducer 110 and microcatheter 105 tothe appropriate angles to treat the first and second lobes of theprostate. This method again is suited for physicians that are familiarwith anatomical landmarks and are accustomed to viewing a rotated imageon the monitor in the OR.

FIGS. 15A and 15B depict the physician utilizing another embodiment of aprobe to treat the two prostate lobes. In the embodiment of FIGS. 5-6,it can be seen that the endoscope 118 is locked in rotationalorientation with introducer 110 and the microcatheter 105—but not withthe handle pistol grip. It can easily be understood a probe can be madethat allows rotational adjustment between the introducer 110 andmicrocatheter 105 relative to the handle pistol grip 124—but thatprovided a bracket that rotationally locks the endoscope 118 to thehandle pistol grip 124. FIGS. 15A-15B depict the use of such anembodiment, wherein the physician can maintain the handle pistol grip124 in the grip-down orientation GD and then rotates only the introducer110 and microcatheter 105. In this embodiment, the image on the monitorwill remain vertical instead of rotated, which may be preferred byphysicians accustomed to laparoscopy in which images are not rotated onthe monitor when instruments are manipulated.

In another aspect of the invention, referring to FIGS. 10-11, themicrocatheter 105 carries a temperature sensor or thermocouple 405 at adistal location therein, for example as indicated in FIG. 10. Thethermocouple is operatively connected to controller 255 to control vapordelivery. In one embodiment, an algorithm reads an output signal fromthe thermocouple 405 after initiation of vapor delivery by actuation oftrigger 275, and in normal operation the thermocouple will indicate aninstant rise in temperature due to the flow of vapor. In the event, thealgorithm and thermocouple 405 do not indicate a typical rise intemperature upon actuation of trigger 275, then the algorithm canterminate energy delivery as it reflects a system fault that hasprevented energy delivery.

In another embodiment, referring again to FIGS. 10-11, the microcatheter105 can carry another temperature sensor or thermocouple 410 in aportion of microcatheter 105 that resides in passageway 148 of theintroducer body 144. This thermocouple 410 is also operatively connectedto controller 255 and vapor source 250. In one embodiment, an algorithmreads an output signal from thermocouple 410 after initiation of vapordelivery and actuation of actuator 308 that delivers an irrigation fluidfrom source 300 to the working end 145 of the probe. The delivery ofirrigation fluid will maintain the temperature in the region of thethermocouple at a predetermined peak level which will not ablate tissueover a treatment interval, for example below 55° C., below 50° C. orbelow 45° C. If the temperature exceeds the predetermined peak level,the algorithm and controller can terminate vapor energy delivery. Inanother embodiment, a controller algorithm and modulate the rate ofcooling fluid inflows based on the sensed temperature, and/or modulatethe vapor flow in response to the sensed temperature. In an alternativeembodiment, the thermocouple 410 can be in carried in a portion ofintroducer body 144 exposed to passageway 148 in which the microcatheterresides.

Method of Use

Referring to FIGS. 16A and 16B, the device and method of this inventionprovide a precise, controlled thermal ablative treatment o tissue infirst and second lateral prostate lobes (or right- and left-side lobes),and additionally an affected median lobe in patients with an enlargedmedian lobe. In particular, the ablative treatment is configured toablate stromal or smooth muscle tissue, to ablate alpha adrenergic(muscle constriction) receptors, and to ablate sympathetic nervestructures. More in particular, the method of ablative treatment isconfigures to target smooth muscle tissue, alpha adrenergic receptors,and sympathetic nerve structures parallel to the prostatic urethrabetween the bladder neck region 420 and the verumontanum region 422 asdepicted in FIGS. 16A-16B. The targeted ablation regions 425 have adepth indicated at D in FIGS. 16A-16B that is less than 2 cm from theprostatic urethra 120, or less than 1.5 cm. Depending on the length ofthe patient's prostatic urethra 120, the number of ablative energydeliveries can range from 2 to 4 and typically is 2 or 3.

In a method of use, the physician would first prepare the patient fortrans-urethral insertion of the extension portion 110 of the probe 100.In one example, the patient can be administered orally or sublingually amild sedative orally or sublingually such as Valium, Lorazepam or thelike from 15-60 minutes before the procedure. Of particular interest, ithas been found that prostate blocks (injections) or other forms ofanesthesia are not required due to lack of pain associated with aninjection of a condensable vapor. The physician then actuates theneedle-retraction actuator 210, for example with an index finger, toretract and cock the microcatheter 105 by axial movement of the actuator(see FIGS. 4-6). By viewing the handle 124, the physician can observethat the microcatheter 105 is cocked by the axial location of trigger210. A safety lock mechanism (not shown) can be provided to lock themicrocatheter 105 in the cocked position.

Next, the physician advances the extension portion 110 of the probe 100trans-urethrally while viewing the probe insertion on a viewing monitorcoupled to endoscope 118. After navigating beyond the verumontanum 422to the bladder neck 420, the physician will be oriented to theanatomical landmarks. The landmarks and length of the prostatic urethracan be considered relative to a pre-operative plan based on earlierdiagnostic ultrasound images or other images, such as MRI images.

The physician can rotate the microcatheter-carrying probe about its axisto orient the microcatheter at an angle depicted in FIG. 13A to treat afirst lobe. Thereafter, the treatment included cocking and releasing themicrocatheter followed by vapor delivery, the moving and repeating thevapor injection for a total of three vapor injections in each lobe. FIG.17 is a schematic view of a method the invention wherein threepenetrations of the microcatheter 105 are made sequentially in aprostate lobe and wherein energy delivery is provided by vapor energy toproduce slightly overlapping ablations or lesions to ablate the smoothmuscle tissue, alpha adrenergic receptors, and sympathetic nervestructures in a region parallel to the prostatic urethra. The method ofthe invention, when compared to prior art, reduces the burden of ablatedtissue and thus lessens the overall inflammatory response leading tomore rapid tissue resorption and more rapid clinical improvement.

FIG. 18 is a sagittal MRI image of an exemplary BPH treatment of apatient 1 week following the procedure, in which the treatment includedthe following steps and energy delivery parameters. The patient'sprostate weighed 44.3 gms based on ultrasound diagnosis. Amparax(Lorazepam) was administered to the patient 30 minutes before theprocedure. In the treatment of the patient in FIG. 18, each treatmentinterval consisted of 10 seconds of vapor delivery at each of sixlocations (3 injections in each lobe). Thus, the total duration ofactual energy delivery was 60 seconds in the right and left prostatelobes. The energy delivered was 6 cal/sec, or 60 cal. per treatmentlocation 425 (FIG. 16A) and a total of 360 calories in total to createthe ablation parallel to the prostatic urethra, which can be seen in theMRI of FIG. 18. In the patient relating to the MRI image of FIG. 18, themedian lobe was also treated with a single 10 second injection of vapor,or 50 calories of energy. The vapor can be configured to delivery energyin the range of 5 to 10 cal/sec.

By comparing the method of the present invention (FIG. 17) with theprior art (FIGS. 3A-3B), it can be understood the method and apparatusof the present invention is substantially different than the prior art.FIG. 3A schematically depicts the prior art RF needle that is elongated,typically at about 20 mm in length, which ablates tissue away from theprostatic urethra and does not target tissue close to and parallel tothe prostatic urethra. Second, the prior art RF energy delivery methodsapply RF energy for 1 to 3 minutes or longer which allows thermaldiffusion of effect to reach the capsule periphery, unlike the veryshort treatment intervals of the method of the present invention whichgreatly limit thermal diffusion. Third, the prior art RF energy deliverymethods do not create a uniform ablation of tissue adjacent and parallelto the prostatic urethra to ablate smooth muscle tissue, alphaadrenergic receptors, and sympathetic nerve structures in a regionparallel to the prostatic urethra.

One method corresponding to the invention is shown in the block diagramof FIG. 19, which includes the steps of advancing a probetrans-urethrally to the patient's prostate, extending a energyapplicator or microcatheter into prostate lobes in a plurality oflocations to a depth of less than 2 cm, and then applying energy at eachlocation to create an ablation zone in a continuous region parallel toat least a portion of the prostatic urethra.

Another method of the invention is shown in the block diagram of FIG.20, which includes the steps of advancing a probe trans-urethrally tothe patient's prostate, extending a energy applicator or microcatheterinto prostate lobes in a plurality of locations, and applying energy ateach location for less than 30 seconds to thereby prevent thermaldiffusion to peripheral portions of the lobes.

Another method of the invention is shown in FIG. 21, which includes thesteps of advancing a probe trans-urethrally to the patient's prostate,extending a energy applicator or microcatheter into prostate lobes in aplurality of locations, and applying energy at each location for aselected interval and irrigating the urethra with a cooling fluidthroughout the selected interval of energy delivery. It has been foundthat such a flow of cooling fluid may be useful, and most important theflow of cooling fluid can be continuous for the duration of thetreatment interval since such times are short, for example 10 to 15seconds. Such a continuous flow method can be used in prior art methods,such as RF ablation methods of FIGS. 3A-3B, since the cooling fluidvolume accumulates in the patient's bladder and the long treatmentintervals would result in the bladder being filled rapidly. This wouldlead to additional steps to withdraw the probe, remove the excess fluidand then re-start the treatment.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

What is claimed is:
 1. A vapor therapy system, comprising: a shaftadapted to be inserted into a male urethra; a vapor delivery needle inthe shaft, the needle comprising a vapor exit port; a vapor needledeployment mechanism adapted to move a tip of the needle generallytransverse to the shaft, wherein the vapor needle deployment mechanismcannot move the vapor delivery needle more than 15 mm from the shaft; avapor source; and a vapor delivery actuator adapted to deliver vaporfrom the vapor source into the vapor delivery needle and out of thevapor exit port.
 2. The system of claim 1 wherein the vapor deliveryneedle is movable between a retracted position in which a distal needletip is within the shaft and a deployed position in which the distalneedle tip extends from the shaft.
 3. The system of claim 2 furthercomprising a needle-retraction actuator adapted to retract the vapordelivery needle into the shaft.
 4. The system of claim 1 wherein thevapor delivery needle comprises a non-energy applicator portion thatdoes not include a vapor exit port.
 5. The system of claim 4 wherein thenon-energy applicator portion is approximately the thickness of the maleurethra.
 6. The system of claim 1 wherein the vapor delivery needlecomprises a flexible polymer tube with sharp tip.
 7. The system of claim1 further comprising an irrigation liquid source and an irrigationpassage in the shaft extending from the irrigation liquid source to anirrigation liquid outlet.
 8. The system of claim 7 further comprising anirrigation actuator configured to irrigate a cooling fluid from theirrigation liquid source through the irrigation liquid outlet.
 9. Thesystem of claim 8 wherein the irrigation actuator is configured toirrigate the cooling fluid when the vapor delivery actuator deliversvapor.
 10. The system of claim 8 further comprising an interlock toprevent vapor delivery without irrigation of the cooling fluid.
 11. Thesystem of claim 1 further comprising a handle connected to the shaftthrough an adjustably rotatable connector such that shaft can be rotatedwith respect to the handle.
 12. The system of claim 11 wherein therotatable connector comprises rotational stops at preset angles.
 13. Thesystem of claim 1 further comprising a temperature sensor operablyconnected to a controller to control vapor delivery based on a sensedtemperature.
 14. The system of claim 13 wherein the temperature sensoris configured to sense a temperature of the vapor delivery needle. 15.The system of claim 13 wherein the temperature sensor is configured tosense a temperature of the shaft.
 16. The system of claim 1 furthercomprising a vapor delivery interlock adapted to prevent delivery ofvapor from the vapor delivery needle unless the vapor delivery needle isdeployed.
 17. The system of claim 1 wherein the needle deploymentmechanism further comprises a limit stop adapted to limit a deploymentdistance of the needle.
 18. The system of claim 1 further comprising ascope bore in the shaft sized to accommodate an endoscope, the scopebore having an opening oriented to permit a user to view a distal end ofthe vapor delivery needle through the endoscope.
 19. A vapor therapysystem, comprising: a shaft adapted to be inserted into a male urethra;a vapor delivery needle in the shaft, the needle comprising a vapor exitport; a vapor needle deployment mechanism adapted to move a tip of thevapor delivery needle generally transverse to the shaft, wherein thedeployment mechanism cannot move the vapor delivery needle more than 15mm from the shaft; a scope bore in the shaft sized to accommodate anendoscope, the bore having an opening oriented to permit a user to viewa distal end of the vapor delivery needle through the endoscope; a vaporsource; and a vapor delivery actuator adapted to deliver vapor from thevapor source into the vapor delivery needle and out of the vapor exitport.
 20. The system of claim 19 wherein the needle is movable between aretracted position in which a distal needle tip is within the shaft anda deployed position in which the distal needle tip extends from theshaft.